Efficacy and Safety of Once-Daily Nevirapine- or Efavirenz-Based Antiretroviral Therapy in HIV-Associated Tuberculosis: A Randomized Clinical Trial

摘要: BACKGROUND Nevirapine (NVP) can be safely and effectively administered once-daily but has not been assessed in human immunodeficiency virus (HIV)-infected patients with tuberculosis (TB). We studied the safety efficacy of NVP, compared efavirenz (EFV; standard therapy); both drugs were combination 2 nucleoside reverse-transcriptase inhibitors. METHODS An open-label, noninferiority, randomized controlled clinical trial was conducted at 3 sites southern India. HIV-infected TB treated a short-course anti-TB regimen (2EHRZ(3)/4RH(3); [2 months Ethambutol, Isoniazid, Rifampicin, Pyrazinamide / 4 Isoniazid Rifampicin] thrice weekly) to receive EFV dose 600 mg or NVP 400 (after 14 days 200 once daily) didanosine 250/400 lamivudine 300 after months. Sputum smears mycobacterial cultures performed every month. CD4+ cell count, viral load, liver function test results monitored periodically. Primary outcome composite death, virological failure, default, serious adverse event (SAE) 24 weeks. Both intent-to-treat per protocol analyses done, planned interim performed. RESULTS A total 116 (75% [87 patients] whom had pulmonary TB), mean age 36 years, median count 84 cells/mm(3), load 310 000 copies/mL, randomized. At weeks, 50 59 group 37 57 suppression (P = .024). There no deaths, 1 SAE, 5 treatment failures arm, SAEs, 10 arm. The halted by data monitoring board second analysis. Favorable outcomes observed 93% arm 84% .058). CONCLUSIONS Compared didanosine, lamivudine, EFV, inferior associated more frequent virologic failure death. Clinical Trials Registration. NCT00332306.